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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 3 FDA device recalls.

Clear
DateProductReasonClassFirm
Oct 28, 2014 Soft Contact Lens Portions of the lots may contain units with an incorrect lens axis condition. Class II Cooper Vision Caribbean Corp.
Sep 17, 2014 ProClear Toric contact lenses are made from a material containing 62%... Routine quality monitoring system has identified that a limited number of lots were manufactured... Class III Cooper Vision Caribbean Corp.
Nov 9, 2012 AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses The lenses exceeded the acceptance limit for silicone oil residual. Class II Cooper Vision Caribbean Corp.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.